Knotless all suture tissue repair

ABSTRACT

A knotless tissue repair assembly for attachment of tissue to bone includes an anchoring implant with a length of suture threaded therethrough. The implant is preferably a soft flexible three-dimensional structure. The implant may be actuated from a first elongate low profile shape into a second short radially expanded shape having a larger diameter than the hole through which it was placed. The suture extends through the anchor, through a tissue to be secured, and back through a designated suture-binding region or passageway within the anchor enabling the suture to be secured therein and without the need for a physician to tie a knot. Further tension applied to a suture leg approximates the tissue to the anchor until a desired tension or distance between the tissue and anchor is achieved.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. non-provisionalapplication Ser. No. 14/575,120 filed Dec. 18, 2014, which claims thebenefit of provisional patent application No. 61/918,796, filed Dec. 20,2013, and entitled “KNOTLESS ALL SUTURE ANCHOR”, the full disclosure ofwhich is incorporated herein by reference. This application is alsorelated to PCT application number PCT/US14/71164 filed Dec. 18, 2014.

BACKGROUND OF THE INVENTION

There is an increasing demand for more types of minimally invasivesurgical techniques. Because endoscopic and arthroscopic surgery tendsto result in lower morbidity than open surgery, the minimally invasivesurgical techniques are very appealing to both patients and physicians.These technologically-advanced procedures include many forms of softtissue to soft tissue repairs and soft tissue to bone repair. Examplesof these (procedures in orthopedic surgery include rotator cuff repair,labral repair, biceps tenodesis, and anterior cruciate ligamentreconstruction. Other examples in other surgical subspecialties include,but are not limited to, hernia repair, hysterectomies, and laparoscopicgastric bypass.

Many orthopedic surgery procedures involve the use of anchoring devicesthat attach soft tissue to bone. Most of these procedures and techniquesrely on the use of polymers, metal, or biodegradable compounds. The useof these materials often requires relatively large holes placed in bone.Conventional (knotted) suture anchors utilize a sliding arthroscopicknot (ex: SMC, Weston, etc) plus the addition of up to 6 alternatinghalf hitches. This knot stack can be up to 10 mm high, and causeirritation in some patients. If these devices ever loosen, one is facedwith the issue of having a potentially hard device in a joint, which canplace the patient at risk for developing arthritis. Certain polymericdevices, such as those made with polylactic acid (PLA), can weaken bone,predisposing the patient to fracture. Finally, metal devices can causescatter on MRI, making follow-up MRI's inaccurate.

Additionally, two major challenges facing all surgeons, and endoscopicsurgeons in particular, are knot tying and suture management. Use ofmultiple sutures can lengthen procedure time, producing higher risk tothe patient and lower repair predictability. Endoscopic knot tying isalso very challenging. For example, arthroscopic soft tissue bicepstenodesis requires multiple passes of suture through the tendon androtator cuff, followed by retrieval and knot tying which require a greatdeal of skill.

Solutions have been developed as an alternative to complex suturemanagement, particularly for soft tissue to bone fixation. For example,a knotless anchoring assembly and method that uses only soft, flexiblematerials in repairs has a number of advantages including: 1) the use ofa less-invasive techniques for implantation because the use of amaterial that is less brittle allows the use of smaller holes in bone;2) the ease of MRI use in follow-up; 3) no risk of a hard device lodgingin a joint or body cavity; 4) potentially better tissue incorporation,5) stronger bone and lower risk of bone fracture; 6) the elimination ofsophisticated knot-tying, and 7) elimination of the high profile knotstack, which may cause irritation.

SUMMARY OF THE INVENTION

The description, objects and advantages of the present invention willbecome apparent from the detailed description to follow, together withthe accompanying drawings.

A knotless anchor for securing a tissue to a bone or tissue to tissue ina human or animal includes an implant for inserting into the bone and asuture for joining the tissue to the implant. The suture is loopedthrough the tissue, and drawn through a soft suture-locking tunnelpresent within the implant. Applying a first force in the proximaldirection to the loop of suture causes the first suture-locking tunnelto radially decrease thereby binding the suture and prohibiting thefirst loop from expanding. Applying tension to a first and second end ofthe suture causes the anchoring implant to change from a first elongate,radially narrow, configuration to a second axially shortened, radiallyextended, configuration. When the anchoring implant is located in thebone hole, the anchoring implant may be expanded to its secondconfiguration, thereby locking it in the bone hole.

In embodiments, the suture is fed back into itself, and thesuture-locking tunnel is comprised of an intermediate length or portionof the suture between the suture ends.

In embodiments, the anchor further comprises a second soft elongatesuture-locking tunnel, and wherein applying tension to the first loopcauses each of the first and second suture-locking tunnels to radiallydecrease thereby locking the suture and prohibiting the first loop fromexpanding.

In embodiments, the suture is a braid.

In embodiments, the anchoring implant is a braided structure.

In embodiments, the anchoring implant has a tubular structure when inthe first configuration.

In embodiments, the suture is at least partially interwoven along thesidewalls of the anchoring implant.

In embodiments, the anchoring implant and the first suture consist ofbiodegradable materials.

In embodiments, the anchoring implant is made of a hard material.

In embodiments, an anchor assembly for securing tissue to a bone ortissue to tissue of an animal or human comprises an anchoring implantfor inserting into the bone or tissue, a first suture extending throughthe anchoring implant, a first suture-locking cradle; and a first snareextending through the first suture-locking cradle. The first snare drawsa first end of the first suture through the suture-locking cradle toform a first suture loop through the tissue, wherein applying tension tothe first suture loop actuates the first suture locking cradle to bindthe first suture therein, thereby prohibiting the first suture loop fromexpanding. Applying tension to a terminal end of the suture when theanchoring implant is located in the bone causes the anchoring implant tochange from the first configuration into a second configurationcomprising an axially shortened, and radially extended shape so as tolock the anchoring implant in the hole.

In embodiments, the anchor assembly further comprises a second snareextending through a second suture-locking cradle located along thesuture, and for drawing the first end of the first suture therethrough.

In embodiments, the anchor assembly is configured such that when thefirst end of the first suture is drawn through the first suture-lockingcradle so as to form the first suture loop through the tissue, the firstsuture extends from the tissue, along an exterior surface of thesidewalls, and into the anchoring implant at the distal end of theimplant.

In embodiments, the anchor assembly further comprises an elongateinserter tube, the anchoring implant being disposed within a distallumen of the inserter tube.

In embodiments, the anchor assembly further comprises an inner pushmember located in the inserter tube. The push member comprises a stopsurface in opposition to the proximal end of the anchoring implant, andwherein the inserter tube is axially moveable relative to the pushmember.

In embodiments, the anchor assembly further comprises a pin between theinserter tube and the distal end of the anchoring implant. The pin isadapted to prevent substantial distortion of the anchoring implant whenthe first end of the first suture is drawn by the first snare.

In embodiments, the anchoring implant comprises a soft braidedstructure.

In embodiments, the anchor assembly comprises a knot or loop between theanchoring implant and the first suture.

In embodiments, a method of anchoring a tissue to a bone of a human oran animal without tying a knot comprises: creating a hole into the bone;passing a first end of a suture through the tissue; drawing the firstend of the suture through a first suture-locking cradle at leastpartially located in an anchoring implant thereby forming a first loopof suture extending from the proximal end of the anchoring implant,through the tissue, and returning to the anchoring implant, wherein thesuture-locking cradle comprises a soft elongate passageway; insertingthe anchoring implant into the hole; deploying the soft anchoringimplant in the hole; and approximating the tissue to the soft anchoringimplant.

In embodiments, the method further comprises actuating the firstsuture-locking cradle to create a binding interface with the suturedisposed therein, prohibiting the first loop from being enlarged.

In embodiments, actuating is performed prior to the step of deploying.In other embodiments, the step of actuating is performed by pullingproximally on at least one of a) the tissue and b) the suture connectedto the tissue.

In embodiments, the inserting step comprises inserting an anchoringimplant having a soft braided structure into the hole.

In embodiments, the suture is at least partially interwoven along thesidewalls of the anchoring implant.

In embodiments, approximating the tissue is performed by decreasing thesize of the first loop.

In embodiments, decreasing the size of the first loop is performed bypulling on the first end of the suture.

In embodiments, pulling on the first end of the suture comprisestensioning the suture to a predetermined force.

In embodiments, deploying is performed by shortening axially andexpanding radially the anchoring implant.

In embodiments, the deploying is performed by pulling on at least one ofthe first suture end and a second suture end extending proximally fromthe anchoring implant.

In embodiments, the method further comprises drawing a second end of thefirst suture through a second suture-locking cradle disposed in theanchoring implant, thereby forming a second loop of suture extendingfrom the proximal end of the anchoring implant.

In embodiments, the drawing is performed by capturing the first end ofthe suture in a wire loop of an elongate snare.

In embodiments, the deploying step comprises pulling the soft anchoringimplant against a die to expand a cross section of the soft anchoringimplant.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-6 are side views of a single suture, and illustrate theformation of a plurality of suture locking regions along the suturepath;

FIGS. 7-12 are side views of a soft anchoring implant, and illustratethe formation of a plurality of suture locking regions along the suturepath;

FIG. 13 is a side view of the soft anchoring implant shown in FIG. 12inserted in a bone tunnel;

FIG. 14 is a side view of the soft anchoring implant shown in FIG. 13 ina radially expanded bone-lock configuration;

FIGS. 15-17 are side views, illustrating approximating a tissue to thesoft anchoring implant shown in FIG. 14;

FIG. 18A is a side view of a single suture, and illustrates theformation of a single suture locking region along a suture path;

FIG. 18B is a perspective view of a soft anchoring implant comprising aserpentine shaped suture path and associated suture locking region;

FIG. 18C is a side view of the soft anchoring implant shown in FIG. 18B,deployed in a bone tunnel;

FIG. 18D is a perspective view of a soft anchoring implant comprising adistally disposed anchor alignment loop;

FIG. 18E is a cross sectional view of an anchor assembly including toolsfor snaring the suture tail, advancing the implant into a bone tunnel,deploying the implant in the bone tunnel, and approximating the tissueto the bone;

FIG. 19 is a side view of a soft anchoring implant in a bone tunnelcomprising a plurality of sutures and a suture locking cradle exteriorto the anchor body;

FIG. 20A is a side view of a soft anchoring implant comprising a firstsuture for creating two distinct suture binding regions;

FIG. 20B is a side view of the soft anchoring implant shown in FIG. 20A,shown loaded with a second suture and deployed in a bone tunnel;

FIG. 20C is a side view of a soft anchoring implant comprising a firstsuture for creating an elongate suture binding region extending acrossthe anchor body;

FIG. 20D is a side view of the soft anchoring implant shown in FIG. 20C,shown loaded with a second suture and deployed in a bone tunnel;

FIG. 21 is a side view of a hard anchoring implant, shown loaded with asuture and deployed in a bone tunnel;

FIG. 22A is a side view of a soft anchoring implant comprising a suturepath having a plurality of suture loops extending through a tissue;

FIG. 22B is a side view of the soft anchoring implant shown in FIG. 20A,shown loaded with a suture and located in a bone tunnel; and

FIG. 23 is a side view of a soft anchoring implant comprising aproximally disposed anchor alignment loop.

DETAILED DESCRIPTION OF THE INVENTION

Before the present invention is described in detail, it is to beunderstood that this invention is not limited to particular variationsset forth herein as various changes or modifications may be made to theinvention described and equivalents may be substituted without departingfrom the spirit and scope of the invention. As will be apparent to thoseof skill in the art upon reading this disclosure, each of the individualembodiments described and illustrated herein has discrete components andfeatures which may be readily separated from or combined with thefeatures of any of the other several embodiments without departing fromthe scope or spirit of the present invention. In addition, manymodifications may be made to adapt a particular situation, material,composition of matter, process, process act(s) or step(s) to theobjective(s), spirit or scope of the present invention. All suchmodifications are intended to be within the scope of the claims madeherein.

Methods recited herein may be carried out in any order of the recitedevents which is logically possible, as well as the recited order ofevents. Furthermore, where a range of values is provided, it isunderstood that every intervening value, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range is encompassed within the invention. Also, it iscontemplated that any optional feature of the inventive variationsdescribed may be set forth and claimed independently, or in combinationwith any one or more of the features described herein.

All existing subject matter mentioned herein (e.g., publications,patents, patent applications and hardware) is incorporated by referenceherein in its entirety except insofar as the subject matter may conflictwith that of the present invention (in which case what is present hereinshall prevail). The referenced items are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such material by virtue of prior invention.

Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “an,” “said” and “the”include plural referents unless the context clearly dictates otherwise.It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation. Last, it is to be appreciated thatunless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs.

A suture anchoring implant for securing soft tissue to bone, or tissueto tissue is described herein. In embodiments, the anchor is a soft allsuture implant. A suture extends through the anchor, through a tissue tobe secured, and back through a designated suture locking region orpassageway within the anchor enabling the tissue to be secured andwithout the need for a physician to tie a knot.

FIGS. 1-6 illustrate the formation of a plurality of suture lockingregions along a length of suture in accordance with one embodiment ofthe invention. The anchoring implant is not shown in FIGS. 1-6 tofacilitate understanding of the suture path and locking mechanics.

With reference first to FIG. 1, a length of hollow braided suture 10commences at a first suture end 12 and terminates at a second suture end14. The ends define a suture length therebetween.

In a procedure, a surgeon passes the first suture end 12 through thetissue to be reattached. To pass the suture through the tissue, a widevariety of techniques may be employed including, without limitation, useof the suture passer described in U.S. Publication No. 2011/0118760 toGregoire et al.

With reference to FIG. 2, a first snare 30 is shown routed through aportion 32 of the length of suture. The snare 30 may be a wire membercomprising a loop. An example of a snare and hollow braided suture isshown in U.S. Pat. No. 6,296,659 to Foerster.

The first suture end 12, which has been passed or looped around thetissue, is placed within snare 30, so that the snare may draw the firstsuture end between the suture braids and into the lumen of the length ofsuture. The first suture end 12 may be drawn along the suture lumen in adirection away from the second suture end 14 before exiting the suturelumen a short distance later. As will be described further herein, theregion 32 along the suture length creates a binding interface, suturecradle, or first friction lock region when actuated.

With reference to FIGS. 3-4, the first suture end 12 is snared again ina similar manner to that described in FIG. 2 using a second snare 40.The second snare is prepared or pre-routed so as to draw the firstsuture end 12 back through the braids and inside the lumen of thesuture. More specifically, the first suture end 12 may be drawn into thelumen of the suture at a location between the first friction lock area32 and the tissue and weave in a direction again towards the tissue,before exiting the lumen of the suture to create a second friction lockzone 42. As will be described further herein, the region 42 along thesuture length may create a second binding interface, suture cradle, orfriction lock region when actuated.

With reference FIGS. 5-6, two distinct friction lock areas 32 and 42have been prepared. The suture 10 now has two suture ends 12, 14defining a length of suture in a looped configuration with the tissue 20and two friction locks areas 32, 42. When a load is applied to eitherthe first suture end 12 or second suture end 14, or the tissue 20, thesuture along the first and second friction lock areas 32, 42 willconstrict, bind to itself, and thereby prohibit the loop from expanding.Additionally, the first suture end 12 may be pulled by the user with aForce (F₁) to reduce the length or size of the loop until the tissue isapproximated as desired.

Soft Anchor with Plurality of Suture Locking Regions

FIGS. 7-14 illustrate a soft anchoring implant, and formation of aplurality of suture locking regions along a length of suture forknotless reattachment of tissue to bone.

With reference first to FIG. 7, a soft anchoring implant 70 inaccordance with one embodiment of the invention is shown. The softanchoring implant 70 may be a three-dimensional tubular shape. Theanchor may have one open proximal end and one closed distal end.Exemplary non-limiting dimensions for the implant are in the range of 10mm-30 mm in length and 2 mm-6 mm in width or diameter.

Preferably, an anchoring implant has a first pre-deployed state in whichfibers are relaxed in an elongated state. The fibers of the implant aremore aligned in an orientation parallel to a longitudinal axis and aregenerally more concentrated. In this orientation, the soft anchoringimplant is generally in an elongated state and of a generally smalldiameter with an exemplary width or diameter “D” of 0.06″ to 0.150″ andlength “L” of 0.5″ to 1.0″. The implant may be pulled and manuallymanipulated to achieve this configuration or the use of specializedmanufacturing fixtures may be employed, such as a funnel, tube and/orpin, which may compel the implant to achieve this first configuration tobetter fit within an inserter tube.

In embodiments, the anchor implant is formed from a coarse braidedmaterial. The structure utilized may be a cylindrical, helically woundbraid, such as the common biaxial braid. Pulling the entire braid alongits length (i.e., putting the braid in tension) lengthens and narrowsit. The length (L) is gained by reducing the angle between the braidedthreads of the wound braid at the crossing points of the threads so thatthe braided threads align mostly parallel, which also reduces the radialdistance between opposing sides and hence the overall circumference.When counter traction occurs, the opposite action occurs, and the braidlongitudinally contracts axially and expands radially, in this case byincreasing the angle between the braided threads. This helically woundbraid provides an advantage in that the structure can collapse andelongate naturally due to the alignment of the braids. Non-limitingexamples of a soft anchoring implant include the Q-Fix™ all sutureimplant manufactured by ArthroCare Corporation, Texas, USA, and isgenerally described in U.S. Publication No. 2013/0123810.

With reference again to FIG. 7, and prior to inserting the anchoringimplant 70 into the bone tunnel, a length of suture is threaded throughthe anchoring implant, using a snare as mentioned herein. A suture endmay be passed in a generally distal direction so as to be interwoven inand out of the anchor implant wall, between the material threads in theimplant wall but not necessarily into the threads. The suture ends 82,84 extend or snake through a portion of the anchor implant wall all theway to the implant distal end and then return using a similar weavingpattern through the wall on the opposing side of the anchor so as toexit the anchor implant at the proximal end. This results in a firstsuture end 82 and a second suture end 84, with the length of suturetherebetween interwoven within the anchor implant 70. If suture ends 82,84 were to be pulled at his point, the soft anchor implant 70 wouldshorten in length and expand radially.

However, prior to deploying the soft anchor, the plurality of suturelocking zones or cradles are formed. As described further herein, thesuture is fed or drawn into itself in order to form the plurality ofknotless suture locking regions.

FIGS. 8-12 illustrate formation of the knotless first and second suturelocking regions 86, 96 through the soft anchoring implant 70.

FIG. 8 shows a first snare 90 extending (or drawn) through the lumen ofthe suture locking region 86 of suture that is interwoven within theimplant wall. FIG. 9 shows a second snare 94 extending through the lumenof the suture locking region 96 that is disposed on the opposing side tosuture locking region 86.

FIG. 10 shows a suture strand end 82 passed through the tissue 102 andin the first snare 90. The snare 90 may now be pulled distally, drawingthe suture end 82 through the first half of the anchor, creating thesuture friction lock 86.

FIG. 11 shows the first suture end 82 positioned in second snare 94. Thesnare 94 may now be pulled proximally, drawing the tail of strand 82through the friction lock 96.

FIG. 12 shows the tissue 102 inside the loop created by the length ofsuture extending from the anchor implant 70. Two distinct frictionlocking zones or mechanisms 86, 96 have been created. As describedherein, the plurality of suture locking zones may be actuated by, forexample, pulling on the tissue loop 104, or the tissue 102 itself. Whenthe loop is pulled, the first and second suture locking cradles 86, 96narrow, thereby binding the loop in place and without tying a knot. Thesuture loop is prohibited from expanding when the tissue is pulled.

Also shown in FIG. 12 is a distal tie, loop or knot 98. Knot 98 may beplaced between the suture strand and the soft anchor body. Knot 98 ispreferably placed towards the center of the length of suture and theanchor body. Knot 98 serves to maintain the suture locking mechanismsinside the anchor implant and bone tunnel.

FIG. 13 shows inserting the loaded implant 70 into a hole 110 within abone 112. This step may be done manually using instruments includinghand held inserter tubes, guides, and advancers or dies (not shown inthese figures for facilitating illustration of the internal suturelocking mechanisms).

FIG. 14 shows deploying the anchor by pulling first and second sutureends 82, 84 with force (F₂). A die instrument (not shown) may bepositioned against the proximal end of the anchor 70′ to constrain theanchor in the tunnel and prohibit its upward movement. As shown, theanchor implant expands to a second deployed configuration 70′ underneaththe cortical layer of the bone, creating a bone lock.

FIGS. 15-17 show approximation of the tissue 102 to the bone 112. Thesurgeon may pull on the first suture end 82 to further reduce the loop104 to a smaller loop 104′, and yet smaller loop 104″ corresponding toFIGS. 16 and 17 respectively. The surgeon may further pull on the firstsuture end 82 until a desired tension force T₁ of the tissue 102 to theanchoring implant and bone is created. First and second suture ends maybe trimmed.

Soft Anchor with Single Suture Locking Region

The tissue repair assemblies and implants may have a plurality of suturelocking regions as described above, or in embodiments, the implant mayhave less than a plurality of suture locking regions.

With reference to FIG. 18A, for example, a suture locking mechanism isshown and described having only one friction lock region. FIG. 18A showsthe suture strand in a hole in a bone 152, the anchor implant beingremoved for facilitating understanding of the suture path. The suturefriction lock 155 is shown on the same side as the tissue loop 156.However, in embodiments, the sole friction lock may be disposed oppositethe tissue loop, or on another side of the implant. The suture may bethreaded as described above, except that only one snare loop andfriction lock region are made.

FIG. 18B shows another embodiment having a suture interwoven with a softanchor implant 158. The suture extends across the anchor body in a zigzag or circumferential pattern. The suture is fed back into itself atthe distal end of the anchor, and out the proximal end of the anchor.Tension on the suture loop 156 narrows the suture, creating a suturelock along region 168. Applying tension T₁ to first end and second end164, 166 serves to lock the suture.

FIG. 18C shows the anchoring implant of FIG. 18B deployed in a tunnel inbone 174. Tension is applied as described above to expand the profile ofthe implant from an elongate linear shape 158, to a 3-dimensionalspherical shape 158′. Desirably, the implant is enlarged in the softcancellous bone tissue 174, below the relatively hard cortical bonelayer 176. Pulling further on the first suture end 164 approximates thetissue 160 to the cortical bone 176.

FIG. 18D shows another anchoring implant 182, first suture end 183 andsecond suture end 188 extending proximally from the anchoring implant.The suture is shown threaded or extending through the anchoring implantand through a portion of itself thereby forming a single suture lockingregion 191 along one lateral side of the anchoring implant. Theanchoring implant additionally includes a centering or fixation zone 196formed by the suture making a loop 197 about the distal end of theanchoring implant and being fed back through itself for a predeterminedlength 196. The zone 196 and loop 197 is interwoven at least in partwith the soft anchoring implant which serves to maintain alignment ofthe locking cradle 191 during deployment and tissue approximation.

FIG. 18E shows an anchor assembly 180 including various instruments forinserting the anchoring implant 182 in a bone tunnel. The anchoringimplant 182 is located within a distal section of an inserter tube 184.A die member 186 abuts the proximal end of the anchoring implant. Thedie member serves to prevent the anchor from backing out as it isdeployed and the tissue is approximated.

A suture tail is shown commencing at 183, extending along a firstlateral side of the anchoring implant 182, and forming a distal loop 197and fixation zone 196. The suture further extends along a second lateralside, opposite to the first lateral side, and exits the anchoringimplant at the proximal end to form a bend 199. From bend 199, a length198 of suture continues in the distal direction along the exterior ofsoft anchoring implant.

The suture end 188 is shown extending distally from the soft anchor 182.In an application, and prior to positioning the inserter tube in a bonetunnel, the suture end 188 is passed through a tissue (not shown) andfed into snare loop 190. Snare tail 192 is then pulled proximally,drawing the suture end 188 through a hollow lumen portion of the sutureto form the suture locking cradle region 191 as described in FIG. 18D.

The suture loop, and or suture ends may be pulled proximally from theanchoring implant to actuate the suture lock 191, binding the suture andprohibiting the suture loop from expanding.

A pin 194 (or another stabilizing feature) may be disposed at the distaltip of inserter tube to prevent distortion of the anchoring implantduring snaring or other intermediate steps of the surgical procedure. Inembodiments, the pin is an elongate rigid member removably located atdistal end of the inserter tube, extending in a lateral directionthrough the distal end of the soft anchor, and perpendicular to the axisof the inserter tube.

Once the anchoring implant is connected to the tissue, and properlyloaded with the suture, the pin 194 is removed. The distal end sectionof the inserter tube assembly 184 is advanced into a bone hole. Theinserter tube is retracted, leaving the anchor in an undeployedconfiguration within the hole. The anchor bone lock is actuated tosecure the anchoring implant 182 in the hole as described above. Thesuture ends may be further pulled to approximate the tissue to a finaldesired position and tension.

Although the suture paths shown in FIG. 18E extend along the sidewalls,in embodiments, the suture paths may extend from one sidewall to anotherin a zigzag pattern such as, for example, the suture pattern shown inFIG. 18B discussed herein.

In embodiments, the suture and anchor may be made of non-absorbable orabsorbable materials. Example materials for the suture and implantinclude, without limitation, polyester and poliglecaprone respectively.

FIG. 19 shows another suture anchor assembly 200 including a firstsuture 202 and a separate independent suture 204. The first suture 202is provided to deploy or lock the anchor in the bone and may be removedonce the anchor implant has been deployed.

The second suture 204 is provided to lock the suture, and approximatethe tissue to the anchor. The second suture 204 may be fed along thelateral and distal sides of the soft suture anchor, through the tissue,and back into a portion 206 of itself (outside of the anchor body) toachieve a suture lock/cradle. Except for the suture cradle portion 206and tissue loop, the second length 204 of suture may follow the samepath as the first length of the suture 202 through the anchoringimplant. It is also noteworthy that in the embodiment shown in FIG. 19,the snaring step to form the suture-locking cradle is performed outsidethe anchor body. In contrast, various embodiments described hereinrequire the snaring step to form the suture-locking cradle to beperformed inside the anchor body.

FIGS. 20A and 20B show another anchoring implant 240 adapted to operatewith two sutures: a first suture for locking the anchor in bone, and asecond suture for binding the sutures. With reference to FIG. 20A, afirst suture 242 extends in the proximal end of the anchor 240, down onelateral sidewall, across the distal end of the anchor, and up anopposing lateral sidewall. When the ends of the first suture are pulled,the anchor changes from an elongate cylindrical shape 240 as shown inFIG. 20A, to a short and more spherical shape 240′ as shown in FIG. 20B.Consequently, the anchor may be selectively locked in the bone hole.

FIG. 20A also shows a plurality of wire snares 244, 246, 248, 250extending through the suture 242. The various snares are for drawing asecond suture through a plurality of tunnel regions of the first suture242.

FIG. 20B shows the second suture (the first suture 242 not shown forease of illustration) extending through the soft anchoring implant 240′,to the tissue, back through the anchoring implant, and out the proximalend of the implant. The threading or snaring shown in FIGS. 20A and 20B,enables two lengths of sutures to be passed through each of thefrictional suture locking passageways along the sidewalls. Indeed,second suture is drawn through each suture locking cradle for twopasses. This is in contrast to some of the embodiments shown herein inwhich only one pass of the suture was made through a suture locking orfrictional passageway.

FIGS. 20C and 20D show an anchor assembly 280 having one long continuousfriction lock instead of two or more short discrete regions. Forexample, the first suture 282 is shown extending from one side of theanchor, to the other side of the anchor. The snares 284 and 286 extendthrough the entire length of the first suture 282. Consequently, thefrictional lock region shall include the entire length of the firstsuture through the anchor.

FIG. 20D shows a complete path of the second suture joining the tissue290 to the anchor 280′ (the first suture not shown for ease ofillustration). The anchor 280′ is also shown in its deployed bone-lockedposition. The frictional zone 288 shown in FIG. 20D is different thanthat shown in FIG. 20A in that the friction zone extends laterallythrough the anchor 280′ in contrast to exiting at the anchorproximal/distal ends. The suture cradle 288 of FIG. 20D comprises onerelatively long locking region rather than two or more distinct frictionregions extending along the opposing sidewalls.

As described herein it is to be understood that the anchoring assembliesmay vary greatly and use alternate textiles and materials. FIG. 21, forexample, shows a hard anchor assembly 300 in combination with suturelock mechanism(s) along at least one of the sidewalls of the anchor. Oneor more sutures 302 may be deployed about the anchor 300 in a path asshown in FIG. 21. Threading the suture along the path may be carried outwith snares as described herein and as shown and described in FIGS. 1-6,for example. Consequently, two suture locking regions 304, 306 may beprovided to lock the sutures in place prior to deploying the anchor 300.The anchor may then be deployed in the bone (not shown). An example of ahard anchor material is PGA or PLLA.

A wide variety of anchor shapes may be used in combination with thesuture-locking mechanisms described herein. For example, as shown inFIG. 21, the anchor may include barbs or other bone locking features 308to hold the anchor securely in the bone. Additionally, the suture may belooped around or threaded about protrusions, eyelets or other features312, 314 present in the anchor to control the suture path, and bolsterthe desired tissue approximation. Suture ends 322, 324 may be pulled toapproximate tissue 320 after the anchor is deployed in the bone tunnel.

Anchor with Simultaneous Bone and Suture Locking

FIGS. 22A and 22B show another suture locking anchor assembly 400. Theembodiment shown in FIGS. 22A and 22B provides simultaneous a) lockingof anchor implant 404 in a bone tunnel and b) securing the suture 402.With reference to FIG. 22A, a suture 402 is shown threaded around anchorbody 404, terminating at tails 406, 408, and creating two precursortissue loop lengths 410, 412.

Suture tails 406, 408 are passed through the tissue 422. Snares 430,432capture the tails 406, 408 and draw the tails through the suturefriction zones along the anchor sidewalls.

FIG. 22B shows anchor being inserted into the bone tunnel 414. Tails406, 408 are shown pulled proximally which simultaneously locks theanchor in place and binds the sutures. Further tension applied to thesuture tails approximates the tissue 422 to the bone.

FIG. 23 shows another anchor assembly 500 and suture 502 forapproximating tissue 504 to bone. The anchor assembly 500 is shownpositioned in a bone tunnel 510. Suture length 512 has been passedthrough tissue 504 and extends downward into the tunnel 510 along asidewall.

In particular, suture 512 extends in a downward direction, between theanchor sidewall and a wall of the bone tunnel. Suture 512 terminates atsuture tail or end 514. A snare 516 extends through a suture capturezone 520 in the suture. The suture capture zone is wound about andinterwoven with the anchor body 521. By pulling on snare proximal end518, a suture length may be drawn through the suture friction zone orlocking cradle 520. The suture tail is then pulled proximally as desiredto lock the suture, deploy the anchor in the bone, and to furtherapproximate the tissue.

Fixation loop 522 is provided to maintain alignment of the anchor andcradle inside the bone tunnel. Consequently, as the anchor is deployedand suture locked, the anchor body is urged into the tunnel instead ofbeing pulled out of the tunnel.

While preferred embodiments of this disclosure have been shown anddescribed, modifications thereof can be made by one skilled in the artwithout departing from the scope or teaching herein. The embodimentsdescribed herein are exemplary only and are not intended to be limiting.Because many varying and different embodiments may be made within thescope of the present inventive concept, including equivalent structures,materials, or methods hereafter thought of, and because manymodifications may be made in the embodiments herein detailed inaccordance with the descriptive requirements of the law, it is to beunderstood that the details herein are to be interpreted as illustrativeand not in a limiting sense.

We claim:
 1. An anchor assembly for knotlessly securing a tissue to abone or tissue to tissue in a human or animal, the anchor comprising: ananchoring implant defining an elongate flexible body with a distal andproximal end, the anchoring implant having a first configuration forinserting into a bone or tissue and a second configuration wherein theanchoring implant is axially shortened, and radially extended so as toanchor the anchoring implant with the bone or tissue; and a first sutureextending through the anchoring implant, wherein the first suture isinterwoven with the anchoring implant and around an outer surface of thedistal end of the anchoring implant and includes a suture lockingregion; wherein applying tension to at least one end of the first suturewhen the anchoring implant is located in the bone or the tissue causesthe anchoring implant to change from the first configuration into thesecond configuration; and wherein when a length of suture that isoperatively coupled to the tissue is disposed along the suture lockingregion, applying tension to the at least one end of the first sutureknotlessly secures the length of suture within the suture locking regionand thereby knotlessly locks the tissue to the bone; wherein the lengthof suture and the first suture are two separate sutures.
 2. The anchorassembly of claim 1 wherein the length of suture and the first sutureare two separate sutures and wherein the length of suture extendsthrough the tissue and then extends from the anchoring implant proximalend, along an external surface of the anchoring implant towards theanchoring implant distal end, through the suture locking region, aroundan outer surface of the distal end of the anchoring implant to anopposing side of the implant and back to the anchoring implant proximalend along the outer surface of the anchoring implant.
 3. The anchorassembly of claim 1 wherein the suture-locking region is interwoven withthe anchoring implant.
 4. The anchor assembly of claim 3, whereinapplying a first tension in a proximal direction to at least one end ofthe first suture causes the anchoring implant to change to the secondconfiguration and applying a second tension, causes the suture-lockingregion to radially decrease thereby knotlessly locking the length ofsuture.
 5. The anchor assembly of claim 1, wherein the anchoring implantis a braided structure.
 6. The anchor assembly of claim 1 furthercomprising a snare extending through a portion of the suture-lockingregion, configured to draw the length of suture through thesuture-locking region.
 7. An anchor assembly for knotlessly securing atissue to a bone in a human or animal, the anchor comprising: ananchoring implant comprising a flexible braided body defining alongitudinal axis, distal and proximal ends; a first suture interwovenwith the anchoring implant, and also extending along a first lateralsidewall of the anchoring implant, across the distal end and up anopposing lateral side wall, the first suture defining a suture-lockingregion adjacent the anchoring implant; and a second suture that isconfigured to operatively couple to the tissue and also extend along thefirst lateral sidewall of the anchoring implant, across the distal endand up the opposing lateral side wall; wherein the second suture extendsthrough the suture-locking region.
 8. The anchor assembly of claim 7wherein applying a first tension in a proximal direction to a first endof the first suture causes the suture-locking region to radiallydecrease thereby locking the second suture with the anchoring implant.9. The anchor assembly of claim 7 wherein applying tension to either orboth a first suture end or a second suture end of the first suture whenthe anchoring implant is located in the bone causes the anchoringimplant to expand radially so as to anchor the anchor assembly with thetissue or bone.
 10. The anchor assembly of claim 7 further comprising asnare extending through a portion of the suture-locking region,configured to draw an end of the second suture through thesuture-locking region.
 11. An anchor assembly for knotlessly securing atissue to a bone or a tissue to a second tissue in a human or animal,the anchor assembly comprising: an anchoring implant defining anelongate flexible body with a distal and a proximal end, the anchoringimplant having a first configuration for inserting into a bone or secondtissue and a second configuration wherein the anchoring implant isaxially shortened and radially extended so as to anchor the anchoringimplant with the bone or second tissue; and a first suture extendingthrough the anchoring implant, wherein the first suture defines a firstlength portion that is interwoven with the anchoring implant and asecond length portion distinct from the first length portion thatextends across an external surface of the anchoring implant distal endand wherein the first suture includes a suture-locking region extendingalong the anchoring implant; and wherein when a length of suture that isoperatively coupled to the tissue is disposed along the suture lockingregion, applying tension to at least one end of the first sutureknotlessly secures the length of suture with the suture locking regionand thereby knotlessly locks the tissue to the bone or second tissue;wherein the length of suture is a second suture that extends along theanchoring implant parallel to the first length portion and the secondlength portion.
 12. The anchor assembly of claim 11 wherein applyingtension to at least one end of the first suture when the anchoringimplant is located in the bone or the second tissue causes the anchoringimplant to change from the first configuration into the secondconfiguration.
 13. The anchor assembly of claim 11 wherein the length ofsuture is a second suture, that extends from the tissue towards theanchoring implant, along a lateral sidewall of the anchoring implant,across the distal end and up an opposing lateral sidewall of theanchoring implant.
 14. The anchor assembly of claim 11 wherein thesuture-locking region is interwoven with the anchoring implant.
 15. Theanchor assembly of claim 11 further comprising a snare extending throughthe suture-locking region, configured to draw an end of the length ofsuture through the suture-locking region.